1、(保密论文在解密后应遵守此规定) 导师签名: 日 期:目 录中文摘要1英文摘要3符号说明6前言7第一部分 四种抗癫痫药物血药浓度监测结果回顾分析1 仪器与试剂92 方法92.1 采集血样92.2 测定方法92.3 血药浓度判断标准93 结果93.1 2006-2009年4种抗癫痫药物各年度血药浓度监测结果103.1.1 2006年4种抗癫痫药物血药浓度监测结果103.1.2 2007年4种抗癫痫药物血药浓度监测结果123.1.3 2008年4种抗癫痫药物血药浓度监测结果143.1.4 2009年4种抗癫痫药物血药浓度监测结果163.2 2006-2009年4种抗癫痫药物各年度汇总分析183.2
2、.1 2006年4种抗癫痫药物监测汇总分析183.2.2 2007年4种抗癫痫药物监测汇总分析193.2.3 2008年4种抗癫痫药物监测汇总分析203.2.4 2009年4种抗癫痫药物监测汇总分析213.3 2006-2009年4种抗癫痫药物监测分析 223.3.1 2006-2009年丙戊酸钠血药浓度测定结果分析 223.3.2 2006-2009年卡马西平血药浓度测定结果分析 233.3.3 2006-2009年苯巴比妥血药浓度测定结果分析 243.3.4 2006-2009年苯妥英钠血药浓度测定结果分析 253.4 2006-2009年4种抗癫痫药物监测人次、年龄和性别汇总分析263.
3、4.1 2006-2009年4种抗癫痫药物监测人次所占比例 263.4.2 2006-2009年4种抗癫痫药物应用患者年龄汇总分析 273.4.3 2006-2009年4种抗癫痫药物在有效浓度范围内男女所占比例汇总分析 283.4.4 2006-2009年4种抗癫痫药物低于浓度范围男女所占比例汇总分析 303.4.5 2006-2009年4种抗癫痫药物高于浓度范围男女所占比例汇总分析 313.5 2006-2009年4种抗癫痫药物测定次数分布情况 334讨论 34第二部分 环孢素血药浓度监测结果回顾分析1 仪器与试剂 362 方法 362.1采集血样 362.2测定方法 362.3血药浓度判断
4、标准 363 结果363.1 20062009年各年度环孢素血药浓度监测分析 373.2 20062009年四年内环孢素血液浓度监测汇总分析 383.3 年龄与环孢素血药浓度监测汇总分析 403.4 不同性别与环孢素血药浓度监测汇总分析 413.5 环孢素监测次数汇总分析 434 讨论 44全文结论45参考文献48致 谢51攻读学位论文期间发表的学术论文52 LISTChinese abstract1English abstract3Abbreviations6Introduction7The first part Retrospective analysis of blood concent
5、ration monitoring of 4 kind anti-epileptic drugs1 Instruments and reagents92 Methods2.1 Blood sampling2.2 Method for determination2.3 Judgment standard of blood drug concentration3 Results3.1 The results of blood concentration monitoring of 4 kind anti-epileptic drugs in each year from 2006 to 20091
6、03.1.1 The results of blood concentration monitoring of 4 kind anti-epileptic drugs in 20063.1.2 The results of blood concentration monitoring of 4 kind anti-epileptic drugs in 2007123.1.3 The results of blood concentration monitoring of 4 kind anti-epileptic drugs in 2008143.1.4 The results of bloo
7、d concentration monitoring of 4 kind anti-epileptic drugs in 2009163.2 Summary analysis of 4 kind anti-epileptic drugs in each year from 2006 to 2009183.2.1 Summary analysis of 4 kind anti-epileptic drugs in 20063.2.2 Summary analysis of 4 kind anti-epileptic drugs in 2007193.2.3 Summary analysis of
8、 4 kind anti-epileptic drugs in 2008203.2.4 Summary analysis of 4 kind anti-epileptic drugs in 2009213.3 Analysis of blood concentration monitoring of 4 kind anti-epileptic drugs from 2006 to 2009223.3.1 Analysis of blood concentration monitoring of valproic acid sodium from 2006 to 20093.3.2 Analys
9、is of blood concentration monitoring of carbamazepine from 2006 to 2009233.3.3 Analysis of blood concentration monitoring of phenobarbital from 2006 to 2009243.3.4 Analysis of blood concentration monitoring of phenytoin sodium from 2006 to 2009253.4 Summary analysis of monitoring person-time, age an
10、d sex of 4 kind anti-epileptic drugs from 2006 to 2009263.4.1 The ratio of monitoring person-time of 4 kind anti-epileptic drugs from 2006 to 20093.4.2 The summary analysis of age using 4 kind anti-epileptic drugs from 2006 to 2009273.4.3 The ratio of male and female in effective concentration range
11、 of 4 kind anti-epileptic drugs from 2006 to 2009283.4.4 The ratio of male and female lower than effective concentration range of 4 kind anti-epileptic drugs from 2006 to 2009303.4.5 The ratio of male and female more than effective concentration range of 4 kind anti-epileptic drugs from 2006 to 2009
12、313.5 The distribution of determination frequency of 4 kind anti-epileptic drugs from 2006 to 2009334 Discussion34The second part Retrospective analysis of blood concentration monitoring of Cyclosporine1Instruments and reagents362.1Blood sampling3 Results3.1 Analysis of blood concentration monitorin
13、g of Cyclosporine in each year from 2006 to 2009373.2 Summary analysis of blood concentration monitoring of Cyclosporine in four years from 2006 to 2009383.3 Summary analysis of age and blood concentration monitoring of Cyclosporine403.4 Summary analysis of different sex and blood concentration moni
14、toring of Cyclosporine413.5 Summary analysis of monitoring frequency of Cyclosporine434 Discussion44Conclusion 45Reference48Acknowledgment51Articles published during postgraduate period5220062009年山东大学齐鲁医院2006-2009 qilu hospital of shandong university blood drug concentration monitoring retrospective
15、ly研究生 专 业 制药工程导 师 中文摘要摘要:目的:回顾性分析2006-2009年所有血药浓度监测情况,以利指导用药。方法:采用回顾性调查分析方法,通过对山东大学齐鲁医院20062009年四种主要抗癫痫药血液浓度监测数据进行分类分析。在不同年龄、性别分别汇总低于有效治疗浓度、有效治疗浓度、高于治疗浓度数据。结果:4种抗癫痫药物中在监测人次上丙戊酸钠所占比例最大(43.41%),其次是卡马西平(32.27%)、苯妥英钠(14.00%)、苯巴比妥(10.33%);4种抗癫痫药物在03岁和60岁以上监测人次最少,314岁监测人次(436人约占28.55%)最多;4种抗癫痫药物男性达有效治疗浓度(
16、31.14%)的比例要远高于女性(12.17%),低于有效治疗浓度所占比例男性(29.52%)高于女性(16.43%),高于有效治疗浓度所占比例男性(6.33%)高于女性(4.87%);4种抗癫痫药物监测1次比例最高(94.26%),监测2次比例(4.54%),监测3次以上所占比例极少;4种抗癫痫药物在有效治疗浓度比较:卡马西平最高(57.97%),其次是苯巴比妥(55.26%)、丙戊酸钠(42.11%),苯妥英钠最低(16.41%)。1525例四种抗癫痫药物血药浓度监测结果在有效治疗浓度所占比例为42.94%,低于有效治疗浓度所占比例为46.79%,高于有效治疗浓度所占比例为10.27%。将
17、环孢素的具体监测结果分为6个区段进行比较,结果显示分布于450g/L的结果仅占总例次的1.2%3.3%,6.6%9.7%和1.8%7.6%;大部分监测结果分布在50150g/L,150250g/L,250350g/L 3个区段,50450g/L有效浓度范围内的占91%,各年度监测结果差别意义不大;4346例环孢素监测人次中男性占3047次(70.18%),女性占1296次(29.82%),男性的有效治疗浓度内(正常值)所占比例(92.64%)略低于女性(94.21%),P0.05没有差异。5种药物进行5833例次监测,达有效血药浓度的4670例次,占总数80.1%;未达有效血药浓度的1163例
18、次,占总数19.9%;结论:在应用苯妥英钠、卡马西平、苯巴比妥、丙戊酸钠、环孢素时,应全面分析患者的剂量方案、用药史、重要的实验室数据,结合血药浓度监测结果和临床疗效随时调整剂量,真正做到个体化治疗。临床药师和医师应联合,充分利用TDM 技术,建立一个长期有效的治疗方案,最大限度保证患者用药安全、有效、经济。关键词:药物监测;血药浓度;回顾性分析2006-2009 QILU HOSPITAL OF SHANDONG UNIVERSITY BLOOD DRUG CONCENTRATION MONITORING RETROSPECTIVELYPostgraduate: SUNGUODDONGMaj
19、or: Pharmaceutical EngineeringTutor: GUORUICHENABSTRACTAbstract: Objective: The blood concentration monitoring from 2006 to 2009 was analysed retrospectively to direct the use of medicine. Methods: The data as name, age, sex and monitoring results were summarized by analysing the blood concentration
20、 monitoring data of main anti-epileptic drugs and cyclosporine which were collected by qilu hospital of shandong university from 2006 to 2009. The data which was lower than effective concentration, equal to effective concentration and more than effective concentration was summarized. Results: Among
21、the monitoring person-time of the 4 kind anti-epileptic drugs, the largest percentage (43.41%) was valproic acid sodium followed by carbamazepine (32.27%), phenytoin sodium (14.00%) and phenobarbital (10.33%). The monitoring person-time of 4 kind anti-epileptic drugs in the age of 03 and 60 years ol
22、d was lowest, which was most in the age of 314 (436 person). The ratio of male who reached effective concentration of 4 kind anti-epilietic drugs was 31.14%, more than the ratio of female which was 12.17%. The ratio of male whose blood concentration was lower than effective concentration was 29.52%,
23、 more than the ratio of female which was 16.43%. The ratio of male whose blood concentration more than effective concentration was 6.33%, more than the ratio of female which was 4.87%. The ratio of monitoring one time was highest which was 94.26%, the ratio of monitoring two times was 4.54%, the rat
24、io of monitoring three times was very low. The ratio of reaching effective concentration of 4 kind anti-epileptic drugs, carbamazepine was highest which was 57.97%, followed by phenobarbital (55.26%), valproic acid sodium (42.11%) and phenytoin sodium (16.41%). Among 1527 patients who were treated with 4 kind anti-epileptic drugs, the ratio of reaching effective concentration was 42.94%, the ratio of lower than effective co
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